Standard Operating Procedure for Regulatory Compliance and Documentation

1) Purpose

The purpose of this SOP is to outline procedures for ensuring regulatory compliance through proper documentation practices within the pharmaceutical manufacturing facility.

2) Scope

This SOP applies to all personnel involved in the creation, review, approval, and maintenance of regulatory documentation within the pharmaceutical manufacturing facility.

3) Responsibilities

3.1 Regulatory Affairs (RA) Team

• Monitor regulatory requirements and update documentation accordingly.
• Review and approve regulatory submissions and documentation.

3.2 Quality Assurance (QA) and Quality Control (QC) Teams

• Ensure compliance with documentation procedures and standards.
• Provide support in document review and approval processes.

4) Procedure

4.1 Document Creation and Review

1. Create documents following standardized templates and formats.
2. Review documents for accuracy, completeness, and compliance.

4.2 Document Approval and Control

1. Obtain approvals from designated personnel as per approval matrix.
2. Establish document control procedures for versioning and distribution.

4.3 Regulatory Submission

1. Prepare and compile necessary documentation for regulatory submissions.
2. Submit documentation to regulatory authorities within specified timelines.

4.4 Documentation Maintenance

1. Archive and maintain records of all regulatory documentation.
2. Update documents as per change control procedures.

5) Abbreviations, if any

SOP: Standard Operating Procedure; RA: Regulatory Affairs; QA: Quality Assurance; QC: Quality Control

6) Documents, if any

• Standard Document Templates
• Approval Matrix
• Regulatory Submission Forms

7) Reference, if any

ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
FDA Guidance for Industry: Pharmaceutical Quality System

8) SOP Version

Version 1.0